Current batch release testing of established vaccines emphasizes quality control of the final product and is often characterized by extensive use of animals. This report summarises the discussions of a joint ECVAM/EPAA workshop on the applicability of the consistency approach for routine release of human and veterinary vaccines and its potential to reduce animal use. The consistency approach is based upon thorough characterization of the vaccine during development and the principle that the quality of subsequent batches is the consequence of the strict application of a quality system and of a consistent production of batches. The concept of consistency of production is state-of-the-art for new-generation vaccines, where batch release is mainly based on non-animal methods. There is now the opportunity to introduce the approach into established vaccine production, where it has the potential to replace in vivo tests with non-animal tests designed to demonstrate batch quality while maintaining the highest quality standards. The report indicates how this approach may be further developed for application to established human and veterinary vaccines and emphasizes the continuing need for co-ordination and harmonization. It also gives recommendations for work to be undertaken in order to encourage acceptance and implementation of the consistency approach.

This report aims to facilitate the implementation of the Three Rs (reduction, refinement and replacement) in the testing of vaccines for regulatory and other purposes. The focus is predominantly on identification of reduction and refinement opportunities in batch potency testing but the principles described are widely applicable to other situations that involve experimental infections of animals. The report should also help to interpret the requirements of the European Pharmacopoeia with regard to the use of alternative tests, humane endpoints and other refinements. Two specific worked examples, for batch potency testing of Clostridium chauvoei and canine leptospira, with recommendations for harmonisation of international test requirements for these and other vaccines, are provided as appendices online.

Current lot release testing of conventional vaccines emphasizes quality control of the final product and is characterized by its extensive use of laboratory animals. This report, which is based on the outcome of an ECVAM (European Centre for Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy) workshop, discusses the concept of consistency testing as an alternative approach for lot release testing. The consistency approach for the routine release of vaccines is based upon the principle that the quality of vaccines is a consequence of a quality system and of consistent production of lots with similar characteristics to those lots that have been shown to be safe and effective in humans or the target species. The report indicates why and under which circumstances this approach can be applied, the role of the different stakeholders, and the need for international harmonization. It also gives recommendations for its implementation.

The European Partnership for Alternative App roaches to Animal Testing (EPAA) is a joint initiative of the European Commission and a number of companies and trade federations active in various industrial sectors. The Partnership was launched on 7 November 2005, at a major conference entitled Europe Goes Alternative, by Commissioners Ver heugen and Potočnik and industry representatives. The purpose of the Partnership is to promote the development of new ‘Three R’ methods (to refine, reduce, and replace the use of animals) as modern alternative approaches to safety testing. The Partnership’s work will focus on mapping existing research, developing new alternative approaches and strategies, and promoting communication, education, and the validation and acceptance of alternative approaches. In this article, EPAA Working Group 5 focuses on the validation process, identifying factors which might delay or hamper the validation of alternative methods.

This is the 61st report of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). The main goal of ECVAM, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which have scientific relevance and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures that would enable it to become well informed about the stateof-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which groups of invited experts would review the current status of non animalbased tests and their potential uses, and make recommendations about the best ways forward (1). The workshop on the potential of physicochemical and immunochemical assays to replace animal tests in the quality control of toxoid vaccines was held at ECVAM on 14–15 April 2005, under the cochairmanship of Coenraad Hendriksen and Gideon Kersten. The objectives of the workshop were: a) to review the state-of-the-art of physicochemical, biochemical and immunochemical tests for the quality control of diphtheria and tetanus toxoid vaccines; and b) to identify possibilities for and limitations to their use in the regulatory framework, i.e. for replacing the use of in vivo tests. The outcome of the discussions and the recommendations of the workshop participants are summarised in this report.